BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3895866 · Received June 26, 2014

    Report

    Report Number
    2939301-2014-15458
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/15/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 7/1/2014 AND EVALUATED BY LIFE SCAN PRODUCT ANALYSIS ON 7/3/2014 WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE PROCESSOR U5. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE A DEFECTIVE EEPROM U6. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THE ONETOUCH ULTRA2 METER HAS A POWER ISSUE (DOES NOT TURN ON). THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF ¿SHAKY, SWEATY, LIGHTHEADED, AND BLURRY VISION¿ AS A RESULT OF THE POWER ISSUE. AT THE TIME OF CONCERN, THE PATIENT WAS ABLE ADMINISTER SELF TREATMENT WITH FOOD AND DRINK. SHE TESTED ON ANOTHER METER AT 120 MG/DL AT AN UNSPECIFIED TIME. DURING TROUBLESHOOTING, THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THE SUBJECT METER DID NOT POWER ON WITH THE INSERTION OF THE TEST STRIPS AND WITH THE POWER BUTTON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE POWER ISSUE BEGAN. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374254 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2901420

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening